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1. www.fda.gov › regulatory-information › search-fda-guidance-documentsClassification of Products as Drugs and Devices and Additional...

   www.fda.gov › regulatory-information › search-fda-guidance-documents

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   Conceptually, all FDA-regulated medical products meet the definition of “drug” under section 201(g) of the FD&C Act, due to the broader scope of the drug definition.

   • RFD

     Written comments and suggestions may be submitted at any...

   • Frequently Asked Questions About Combination Products

     Some FDA regulated products are intended to be used together...

   • Tissue Guidances

     If you need further assistance, please go to Contact FDA....

2. www.fda.gov › drugs › drug-approvals-and-databasesDrugs@FDA Glossary of Terms | FDA - U.S. Food and Drug...

   www.fda.gov › drugs › drug-approvals-and-databases

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   A substance recognized by an official pharmacopoeia or formulary. A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. A substance (other...

3. www.fda.gov › drugs › fda-drug-info-rounds-videosDefinition of a Drug (April 2017) - FDA

   www.fda.gov › drugs › fda-drug-info-rounds-videos

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   Whether a product is regulated as a drug, a cosmetic, or both under the law is determined by a product's intended use. FDA Drug Info Rounds pharmacists discuss the key differences...

4. www.ecfr.gov › current › title-21eCFR :: 21 CFR 210.3 -- Definitions.

   www.ecfr.gov › current › title-21

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   The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.

5. www.accessdata.fda.gov › scripts › cdrhCFR - Code of Federal Regulations Title 21 - Food and Drug...

   www.accessdata.fda.gov › scripts › cdrh

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   22 mar 2024 · Drug, for the purposes of registration and listing under this part, has the meaning given in section 201 (g) (1) of the Federal Food, Drug, and Cosmetic Act. Establishment means a place of...

6. www.accessdata.fda.gov › scripts › cdrhCFR - Code of Federal Regulations Title 21 - Food and Drug...

   www.accessdata.fda.gov › scripts › cdrh

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   22 mar 2024 · Drug substance is an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to...

7. www.msdmanuals.com › home › drugsOverview of Drugs - Overview of Drugs - MSD Manual Consumer...

   www.msdmanuals.com › home › drugs

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   In the United States, the Food and Drug Administration (FDA) is the government agency that decides which drugs require a prescription and which may be sold over the counter. Dietary supplements (for example, medicinal herbs and nutraceuticals) are products intended to supplement the diet.